Trial Outcomes & Findings for Ondansetron, Alcohol Use, and Alcohol-Related Symptoms In HIV+ Persons (NCT NCT01254877)

NCT ID: NCT01254877

Last Updated: 2018-04-17

Results Overview

The Time-line Follow-back (TLFB; Sobell, Sobell, Leo \& Cancilla, 1988) is conducted as an interview administered by trained and certified research staff. The interview obtains participant self-reports of daily drinking, including number and type of alcoholic beverages. These data are used to quantify an individual's drinking pattern including the number of drinks per drinking day and drinking frequency. The TLFB was completed biweekly and quantified over the 16-week medication period

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 357 participants
• Primary outcome timeframe: 16 weeks
• Results posted on: 2018-04-17

Participant Flow

357 persons signed informed consent; 205 were randomized. 137 exclusions were mainly due to insufficient alcohol use (as determined by self-report or biomarker), abnormal QT interval, or significant mental health symptoms that precluded assessment completion. An additional 13 participants withdrew, were discontinued by the investigators or died.

Participant milestones

Measure	Placebo Ondansetron - Sugar Pill Placebo is an oral preparation made to appear and taste like the active drug preparation. placebo ondansetron: Matching placebo will be prepared using a colorless strawberry syrup, simple syrup and flat Schweppes tonic water.	Low Dose Ondansetron (0.2 mg Bid) ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks	Moderate Dose Ondansetron (0.8 mg Bid) Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
Overall Study STARTED	67	69	69
Overall Study COMPLETED	57	58	64
Overall Study NOT COMPLETED	10	11	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ondansetron, Alcohol Use, and Alcohol-Related Symptoms In HIV+ Persons

Baseline characteristics by cohort

Measure	Placebo Ondansetron - Sugar Pill n=67 Participants Placebo is an oral preparation made to appear and taste like the active drug preparation. placebo ondansetron: Matching placebo will be prepared using a colorless strawberry syrup, simple syrup and flat Schweppes tonic water.	Low Dose Ondansetron (0.2 mg Bid) n=69 Participants ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks	Moderate Dose Ondansetron (0.8 mg Bid) n=69 Participants Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration	Total n=205 Participants Total of all reporting groups
Sex: Female, Male Male	46 Participants n=5 Participants	46 Participants n=7 Participants	42 Participants n=5 Participants	134 Participants n=4 Participants
Race/Ethnicity, Customized Black	65 Participants n=5 Participants	66 Participants n=7 Participants	64 Participants n=5 Participants	195 Participants n=4 Participants
Region of Enrollment United States	67 Participants n=5 Participants	69 Participants n=7 Participants	69 Participants n=5 Participants	205 Participants n=4 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	10 Participants n=4 Participants
Age, Continuous	49.7 years STANDARD_DEVIATION 8.7 • n=5 Participants	48.7 years STANDARD_DEVIATION 8.2 • n=7 Participants	47.8 years STANDARD_DEVIATION 9.5 • n=5 Participants	48.7 years STANDARD_DEVIATION 8.8 • n=4 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	23 Participants n=7 Participants	27 Participants n=5 Participants	71 Participants n=4 Participants
Number of drinks per drinking day	9.1 standard alcohol drink STANDARD_DEVIATION 5.5 • n=5 Participants	10.5 standard alcohol drink STANDARD_DEVIATION 7.7 • n=7 Participants	10.0 standard alcohol drink STANDARD_DEVIATION 8.7 • n=5 Participants	9.9 standard alcohol drink STANDARD_DEVIATION 7.3 • n=4 Participants
Number of days abstinent from alcohol/week	2.9 days/week STANDARD_DEVIATION 1.9 • n=5 Participants	3.0 days/week STANDARD_DEVIATION 2.1 • n=7 Participants	3.3 days/week STANDARD_DEVIATION 1.9 • n=5 Participants	3.1 days/week STANDARD_DEVIATION 2.0 • n=4 Participants

PRIMARY outcome

Timeframe: 16 weeks

The Time-line Follow-back (TLFB; Sobell, Sobell, Leo & Cancilla, 1988) is conducted as an interview administered by trained and certified research staff. The interview obtains participant self-reports of daily drinking, including number and type of alcoholic beverages. These data are used to quantify an individual's drinking pattern including the number of drinks per drinking day and drinking frequency. The TLFB was completed biweekly and quantified over the 16-week medication period

Outcome measures

Measure	Placebo Ondansetron - Sugar Pill n=67 Participants Placebo is an oral preparation made to appear and taste like the active drug preparation. placebo ondansetron: Matching placebo will be prepared using a colorless strawberry syrup, simple syrup and flat Schweppes tonic water.	Low Dose Ondansetron (0.2 mg Bid) n=69 Participants ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks	Moderate Dose Ondansetron (0.8 mg Bid) n=69 Participants Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
Number of Alcoholic Containing Drinks Per Drinking Day	5.9 Standard alcohol drinks per drinking day Standard Deviation 3.8	6.1 Standard alcohol drinks per drinking day Standard Deviation 4.3	5.9 Standard alcohol drinks per drinking day Standard Deviation 3.9

PRIMARY outcome

Timeframe: 16 weeks

The Time-line Follow-back (Sobell, Sobell, Leo & Cancilla, 1988) is used to obtain this secondary dependent measure. Alcohol use will be assessed biweekly and quantified over the 16-week medication period. Number of days/week abstinent from alcohol is calculated as the number of abstinent days divided by the number of study medication days (adjusted for days in confinement (e.g., hospitalization; jail)) and multiplied by 7.

Outcome measures

Measure	Placebo Ondansetron - Sugar Pill n=67 Participants Placebo is an oral preparation made to appear and taste like the active drug preparation. placebo ondansetron: Matching placebo will be prepared using a colorless strawberry syrup, simple syrup and flat Schweppes tonic water.	Low Dose Ondansetron (0.2 mg Bid) n=69 Participants ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks	Moderate Dose Ondansetron (0.8 mg Bid) n=69 Participants Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
Number of Days/Week Abstinent From Alcohol	4.7 days/week abstinent from alcohol Standard Deviation 2.2	4.9 days/week abstinent from alcohol Standard Deviation 2.0	4.8 days/week abstinent from alcohol Standard Deviation 2.2

SECONDARY outcome

Timeframe: 16 weeks

Medication side-effects and adverse events were measured using the Systematic Assessment for Treatment of Emergent Events (SAFTEE). The SAFTEE contains 25 detailed questions that systematically address 29 body systems. A trained interviewer elicits information about onset, duration, pattern, and judgment of attribution. For the present trial outcome, we report number of events.

Outcome measures

Measure	Placebo Ondansetron - Sugar Pill n=67 Participants Placebo is an oral preparation made to appear and taste like the active drug preparation. placebo ondansetron: Matching placebo will be prepared using a colorless strawberry syrup, simple syrup and flat Schweppes tonic water.	Low Dose Ondansetron (0.2 mg Bid) n=69 Participants ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks	Moderate Dose Ondansetron (0.8 mg Bid) n=69 Participants Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
Medication Safety	11.4 number of events Standard Deviation 11.1	12.4 number of events Standard Deviation 13.4	11.0 number of events Standard Deviation 12.3

SECONDARY outcome

Timeframe: 16 weeks

The investigators will count the number of subjects who discontinue medication during the 16-week intervention period due to complaints of side effects.

Outcome measures

Measure	Placebo Ondansetron - Sugar Pill n=67 Participants Placebo is an oral preparation made to appear and taste like the active drug preparation. placebo ondansetron: Matching placebo will be prepared using a colorless strawberry syrup, simple syrup and flat Schweppes tonic water.	Low Dose Ondansetron (0.2 mg Bid) n=69 Participants ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks	Moderate Dose Ondansetron (0.8 mg Bid) n=69 Participants Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
Number of Subjects Who Discontinue Due to Side Effects	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 16 weeks

Alcohol-related problems were measured using the Short Inventory of Problems - revised (SIP-R), a self-report inventory of adverse consequences associated with alcohol and drug use. The SIP instructs participants to indicate how often each of 15 consequences has occurred during the past three months ("never," "once or a few times," "once or twice a week," "daily or almost daily"; scored 0-3). Item responses are summed to produce a total score and five subscale scores. Total scores range from 0 - 45.

Outcome measures

Measure	Placebo Ondansetron - Sugar Pill n=67 Participants Placebo is an oral preparation made to appear and taste like the active drug preparation. placebo ondansetron: Matching placebo will be prepared using a colorless strawberry syrup, simple syrup and flat Schweppes tonic water.	Low Dose Ondansetron (0.2 mg Bid) n=69 Participants ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks	Moderate Dose Ondansetron (0.8 mg Bid) n=69 Participants Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
Alcohol-related Problems	6.6 units on a scale Standard Deviation 7.3	7.5 units on a scale Standard Deviation 7.9	8.3 units on a scale Standard Deviation 15.7

SECONDARY outcome

Timeframe: 16 weeks

The investigators will obtain patient self reports of the number of HIV medication doses taken as a function of the total number of doses prescribed. The adherence measure is expressed as the % of prescribed doses.

Outcome measures

Measure	Placebo Ondansetron - Sugar Pill n=67 Participants Placebo is an oral preparation made to appear and taste like the active drug preparation. placebo ondansetron: Matching placebo will be prepared using a colorless strawberry syrup, simple syrup and flat Schweppes tonic water.	Low Dose Ondansetron (0.2 mg Bid) n=69 Participants ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks	Moderate Dose Ondansetron (0.8 mg Bid) n=69 Participants Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
HIV Medication Adherence	92.4 percentage of prescribed doses Standard Deviation 31.6	87.6 percentage of prescribed doses Standard Deviation 37.6	85.4 percentage of prescribed doses Standard Deviation 31.7

Adverse Events

Placebo Ondansetron - Sugar Pill

Serious events: 16 serious events

Other events: 7 other events

Deaths: 1 deaths

Low Dose Ondansetron (0.2 mg Bid)

Serious events: 20 serious events

Other events: 5 other events

Deaths: 0 deaths

Moderate Dose Ondansetron (0.8 mg Bid)

Serious events: 5 serious events

Other events: 8 other events

Deaths: 1 deaths

Serious adverse events

Measure	Placebo Ondansetron - Sugar Pill n=67 participants at risk Placebo is an oral preparation made to appear and taste like the active drug preparation. placebo ondansetron: Matching placebo will be prepared using a colorless strawberry syrup, simple syrup and flat Schweppes tonic water.	Low Dose Ondansetron (0.2 mg Bid) n=69 participants at risk ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks	Moderate Dose Ondansetron (0.8 mg Bid) n=69 participants at risk Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
Psychiatric disorders Acute Alcohol Intoxication	3.0% 2/67 • Number of events 2 • 1 year	8.7% 6/69 • Number of events 6 • 1 year	0.00% 0/69 • 1 year
Respiratory, thoracic and mediastinal disorders Pneumonia/Respiratory Infection	3.0% 2/67 • Number of events 2 • 1 year	5.8% 4/69 • Number of events 5 • 1 year	1.4% 1/69 • Number of events 1 • 1 year
Psychiatric disorders Psychiatric disorder	3.0% 2/67 • Number of events 2 • 1 year	2.9% 2/69 • Number of events 2 • 1 year	5.8% 4/69 • Number of events 4 • 1 year
Gastrointestinal disorders Abdominal pain	6.0% 4/67 • Number of events 4 • 1 year	2.9% 2/69 • Number of events 2 • 1 year	0.00% 0/69 • 1 year
Cardiac disorders cardiovascular event	6.0% 4/67 • Number of events 4 • 1 year	1.4% 1/69 • Number of events 1 • 1 year	0.00% 0/69 • 1 year
General disorders Other	3.0% 2/67 • Number of events 2 • 1 year	7.2% 5/69 • Number of events 5 • 1 year	1.4% 1/69 • Number of events 1 • 1 year

Other adverse events

Measure	Placebo Ondansetron - Sugar Pill n=67 participants at risk Placebo is an oral preparation made to appear and taste like the active drug preparation. placebo ondansetron: Matching placebo will be prepared using a colorless strawberry syrup, simple syrup and flat Schweppes tonic water.	Low Dose Ondansetron (0.2 mg Bid) n=69 participants at risk ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks	Moderate Dose Ondansetron (0.8 mg Bid) n=69 participants at risk Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
Respiratory, thoracic and mediastinal disorders Cough/cold symptoms	4.5% 3/67 • Number of events 3 • 1 year	2.9% 2/69 • Number of events 2 • 1 year	5.8% 4/69 • Number of events 4 • 1 year
Psychiatric disorders Alcohol intoxication/withdrawal	3.0% 2/67 • Number of events 2 • 1 year	1.4% 1/69 • Number of events 1 • 1 year	1.4% 1/69 • Number of events 1 • 1 year
Skin and subcutaneous tissue disorders Rash/wound infection	1.5% 1/67 • Number of events 1 • 1 year	0.00% 0/69 • 1 year	2.9% 2/69 • Number of events 2 • 1 year
General disorders Other	1.5% 1/67 • Number of events 1 • 1 year	2.9% 2/69 • Number of events 2 • 1 year	1.4% 1/69 • Number of events 1 • 1 year

Additional Information

Mary E McCaul

JohnHopkinsU

Phone: 410-955-9526

Email: mmccaul1@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place